1. Medical Writing

 

Medical writing in English and Spanish of:

 

A) Research results

  • Abstracts and posters for scientific congresses
  • Original articles
  • Clinical case reports
  • Narrative reviews
  • Systematic reviews (meta-analysis)
  • Kit of slides for scientific congresses or meetings
  • Publication plan development

B) Research development

  • Clinical research study protocols
  • Patient Information Sheet and Consent Form
  • Clinical research reports (ICH or abbreviated)

C) Regulatory documents

  • Clinical expert reports
  • Value dossiers
  • Dossier for pharmaceutics
  • Product monographs*

D) Other documents

  • Consensus of experts
  • Summaries of discussion groups or scientific meetings
  • Critical appraisal of scientific literature

 

E) Publications (PDF)

 

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2. Research Consultantcy

  • A) Development  and methodology of clinical research projects
  • B) Regulatory affairs
  • C) Marketing projects

 

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3. Training

 

Redacción científica

  • Manuscript writing
  • Abstract and posters
  • Clinical case reports
  • How to develop a clinical research report
  • How to pass a peer review process
  • How to perform scientific presentation in PPT
  • How to develop a clinical research study protocol

Research methodology

  • Critical appraisal of scientific research
  • Epidemiology for non-experts
  • Clinical trials methodology
  • Words and numbers: understanding clinical research

 

Training Experience:

 

-      Specialist of Universidad en Investigación y Tratamiento Interdisciplinar del Dolor (35 créditos ECTS). Universidad del País Vasco. Lecturer, with Profª. Inmaculada Arostegui, of the course“Methodological principles of clinical research in pain” (6 ECTS). Post-graduate on-line course. 2011-2012.

 

-      Master in Pharmacology, Development, Assessment and Rational Use of Drugs (60 ECTS). Universidad del País Vasco. Responsible of the course “Clinical Trials” (3 ECTS). Leioa-Vitoria-San Sebastián, from 2007-2012 (5 editions)

 

-      Master in Neuroscience and Pain. Universidad de Granada. Lecture “Active drugs in CNS”, issue “Assessment of psycho-drugs in humans” ECTS). Granada, 2007-2011.

 

-     Understanding and overcoming the peer review of biomedical journals. Fundación ESAME. Barcelona, November 18th 2008. Director of the course.

 

-      Psychiatry course. Research methodology ¿How to develop research in psychiatry? Lecturer of “The meta-analysis. Meaning and interpretation”. Avila, June 13-14th 2008.

 

-      Workshop: Critical issues of a manuscript: from the title to its publication. Fundación ESAME. Madrid, June 19-20th 2007. Director of the workshop.

 

-      New European regulation about pediatric drugs and clinical trials in children.  Fundación ESAME. Madrid, May 29th 2007. Director of the course.

 

-      Clinical reports: from the regulatory requirements to the strategic communication. Fundación ESAME. Barcelona, January 25th 2007. Director of the course.

 

-      “Active medicines in CNS and drugs” Master in Neuroscience and pain. Universidad de Granada. Granada, November 2006. Lecturer (0,5 ECTS).

 

-      Modelling and simulation of clinical trials in the development of new drugs. IL3. Instituto de Formación Continua. Universitat de Barcelona. May 9th 2006. Coordinator of the course.

 

-      Master in Clinical-Pharmaceutical Research. Escuela Superior de Estudios Farmacéuticos y Universidad de Alcalá. Member of the Master Scientific Committee and lecturer from 2003 to 2006.

 

-      Clinical trials monitorization course. Colegio Oficial de Farmacéuticos de Madrid. Lecturer from 2005 until 2008.

 

-      Course in Research and Development: clinical trials monitorization. Fundación ESAME, Madrid, march-april 2006. Lectures “Getting started with research. The clinical research study protocol: basic structure”, “Design of a clinical trial protocol”, “Statistical analysis and final report of a clinical trial”.

 

-      Master in Clinical Trials Monitorization. Fundación ESAME, Madrid, october 2005-february 2006. Lecture “Communication of research results”

 

-      Course “Design of a clinical study protocol for a clinical trial and an observational study”. Fundación ESAME, Barcelona, June 14th 2005. Lecture “How to write the rationale of a study protocol for a clinical trial and for an observational study”

 

-      II Course for Clinical Research Coordinators/Data managers: update in clinical oncology research. Grupo Español de Cáncer de Pulmón. Bilbao, November 25-26th 2004. Lecture “Treatment size effect measures”.

 

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